Drainage is a common therapeutic approach to manage many malignant and benign GI diseases that result from a blocked or strictured lumen. Some examples include but are not limited to biliary drainage due to malignant or benign biliary obstruction of the common bile duct, duodenal drainage due to benign or malignant duodenal stenosis, and transpapilary gallbladder drainage due to gallstone induced acute cholecystitis.
Drainage can be performed using surgical, percutaneous laparoscopic and endoscopic techniques. Historically endoscopic drainage techniques have generally been limited to native lumen internal drainage only, e.g., transpapilary or within the GI tract itself. If the native lumen could not be endoscopically accessed to provide drainage, the patient was typically referred to the interventional radiologist for percutaneous drainage, or as a last resort to the surgeon. Recent advances in endoscopic ultrasound (EUS) have offered less invasive transmural internal drainage alternatives (e.g., going outside the native lumen) for percutaneous or surgical drainage techniques.
Current delivery systems for stents in transmural EUS internal drainage applications face several challenges, including the risk of leak outside of the native lumen that can result in severe morbidity or mortality as well as complexity of the delivery system that make the procedure cumbersome and time consuming. Drainage devices can be used for internal drainage between various organs. Some of the envisioned options are duodenum-CBD, gastric-hepatic, gastric-jejunum, gallbladder-duodenum, gallbladder-jejunum, and gastric-pancreas. Various complications may arise in the delivery and use of drainage systems. For example, perforating the walls of organs during delivery of drainage systems can result in the contents contained within that organ to migrate into areas of the body which are not tolerant of the leaked contents. To mitigate the risk of leaks, the walls of the two organs being perforated can be forced in to direct contact with each other, so that organ contents will pass from one organ in to the other, and not into unintended anatomy. Various procedures include use of a thin needle to penetrate, and thus fenestrate, the organs (e.g., under continuous real-time ultrasound guidance).